Kornimate/medical-research-clean huggingface dataset:
oxford - fibrates in aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: aortic stenosis (as) is characterised by left ventricular (lv) hypertrophy and altered myocardial substrate metabolism. peroxisome proliferator-activated receptor (pparα), a regulator of lipid metabolism is deactivated in pressure overload hypertrophy such as in as and can lead to dysregulation of fatty acid oxidation, myocardial triglyceride accumulation (steatosis) and lipotoxicity. the investigators propose a proof-of-concept study to investigate the effect of altering myocardial triglyceride (mtg) using a pparα agonist, fenofibrate on cardiac physiology in patients with asymptomatic moderate-severe as. the primary endpoint is a change in mtg assessed by magnetic resonance spectroscopy at baseline and after 6 months of treatment. exploratory endpoints are changes in cardiac physiology including myocardial deformation (strain) as assessed by cardiac magnetic resonance imaging. the investigators hypothesise that pharmacological reduction of mtg with a pparα agonist will result in steatosis regression and changes in cardiac physiology.

this is a single-centre, proof-of-concept study to investigate the effect of altering mtg content using fenofibrate on cardiac physiology in patients with asymptomatic moderate-severe as. all patients will participate in a randomised, double-blind, placebo- controlled design for 6 months. as will be graded according to the british society of echocardiography's transthoracic echocardiography guidelines. sixty two eligible patients will be recruited in total, of which forty nine patients will be randomised to receive 200 mg daily oral fenofibrate and thirteen patients will receive matching placebo for 6 months. all patients will undergo 1h-mrs to assess mtg, 31p-mrs to assess myocardial energetic (phosphocreatine-to-atp ratio - pcr/atp), standard cardiac magnetic resonance imaging to assess lv strain, lv mass, late gadolinium enhancement (fibrosis), physiological exercise assessments to measure maximum oxygen consumption (vo2 max) and 6-minute walking distance. bloods will be drawn for cholesterol, renal and liver function, glucose and free fatty acids. all tests will be done at baseline and after 6 months' treatment with fenofibrate/placebo.

Eligibility criteria:
inclusion criteria: * asymptomatic moderate to severe as (with at least two of the following: aortic valve area \ 36 mmhg or mean pressure gradient \>25 mmhg) * not planned aortic valve replacement or transcatheter aortic valve implantation (tavi) * age \>18 * no other significant valvular pathology * no contraindication to magnetic resonance imaging. exclusion criteria: * known coronary artery disease, history of angina, myocardial infarction or presence of regional wall motion abnormalities * other underlying cardiomyopathy * left ventricular ejection fraction\<50% * uncontrolled hypertension * diabetes mellitus * liver impairment * pregnancy and lactation * body mass index \>35 kg/m2 * renal impairment (egfr\<30 ml/min) * intolerance to or concurrent use of fibrates or pparα agonists.
biomarkers in different types of amyotrophic lateral sclerosis (als) patients being treated with edaravone

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study is being conducted to help the investigators better understand how the new fda approved medication edaravone (also known as radicava) works in subsets of patients with als. the investigators are also trying to understand if there are specific als patients, with different presentations of als, who might benefit most from this medication. also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of als there is no study medication being offered in this trial. edaravone is prescribed as part of regular care. in this trial we are collecting blood, urine, and spinal fluid samples in als patients who are taking edaravone and als patients who are not taking edaravone to measure certain markers that could indicate why the drug may be working in a specific type of als.


Eligibility criteria:
inclusion criteria: 1. either possible, probable, or definite als, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar 2. with or without cognitive involvement 3. willing to participate 4. on no experimental treatment 5. ages 18 - 85 6. no prior exposure to edaravone (radicava) 7. on a stable dose of riluzole for 30 days or off riluzole 8. male or female 9. females of childbearing age must use contraception exclusion criteria: 1. unstable medical illness 2. abnormal liver function (\>2x uln) 3. unlikely to survive for 26 weeks
lipiflow versus warm compresses in parkinson's disease

Conditions: Meibomian Gland Dysfunction

Summary: the lipiflow system (tearscience, morrisville, nc) is an in-office fda approved treatment for meibomian gland dysfunction. it relieves meibomian gland obstruction through the use of heat and pulsatile pressure. a recent study has observed that a single treatment with the lipiflow system can decrease dry eye symptoms and objective findings of meibomian gland dysfunction for 1 year. we aim to see if the lipiflow system will be beneficial in patients with parkinsons disease who may have difficulty performing normal meibomian gland dysfunction treatment.

objectives to determine whether a single treatment with thermal pulsation relieves dry eye symptoms (primary objective) and improves objective findings of meibomian gland dysfunction in patients with parkinsons disease. methods and measures design * randomized, controlled trial * patient eyes will be randomized to either receive a single thermal pulsation treatment the fda-approved lipiflow thermal pulsation system or to use traditional eyelid hygiene or to use traditional eyelid hygiene

Eligibility criteria:
patients with parkinsons disease and dry eye attributed to meibomian gland dysfunction inclusion criteria: * medical diagnosis of parkinsons disease * \> 18 years-old * reported dry eye symptoms within 3 months of baseline examination with a standard patient evaluation for eye dryness (speed) score ≥ 6 at baseline visit * evidence of meibomian gland obstruction (based on a total meibomian gland secretion score of ≤ 12 for 15 glands of the lower lid) * willingness to stop dry eye medications including antibiotics, non-steroidal and anti-inflammatory drugs, and corticosteroids for 2 weeks prior to treatment and during the duration of the study exclusion criteria: * active intraocular inflammation * ocular surface abnormality that could potentially compromise corneal integrity in either eye
hydrotherapy versus physiotherapy for short-term rehabilitation after primary tkr

Conditions: Osteoarthritis; Total Knee Replacement

Summary: primary objective: to compare the effects of short term therapy post total knee replacement (tkr) between a hydrotherapy treatment group and a physiotherapy treatment group. secondary objectives: to compare the effects of short term therapy post total knee replacement (tkr) between a hydrotherapy treatment group and a physiotherapy treatment group based on measurements of timed up and go (tug, as primary outcome), range of motion, pain and quality of life.


Eligibility criteria:
inclusion criteria: * candidates for first total knee replacement surgery. * age over 18. * diagnosed with osteoarthritis. * consent to participate in the trial. exclusion criteria: * - rheumatic diseases. * neurological diseases involving lower limbs. * prior knee surgery in operated knee. * secreting surgical wound. * skin diseases. * incontinence. * incapable of signing informed consent. * patients living outside jerusalem

Keywords: osteoarthritis total knee replacement
study of oral zileuton in the treatment of moderate to severe facial acne vulgaris

Conditions: Acne Vulgaris

Summary: tissue inflammation is a major component of the acne disease process. leukotriene b4 (ltb4) is thought to be a major player in the development of tissue inflammation. synthesis of ltb4 is controlled by the enzyme 5-lipoxygenase. zileuton blocks the activity of 5-lipoxygenase. this study will test the safety and efficacy of zileuton in the treatment of facial acne.


Eligibility criteria:
inclusion criteria: * moderate to severe facial acne vulgaris * 20 to 60 facial inflammatory lesions * 10 to 200 facial non-inflammatory lesions * no more than 3 facial nodular cystic lesions exclusion criteria: * uncontrolled systemic disease * use of systemic or topical acne therapy within 14 days of study * use of systemic retinoids within past 2 years * skin diseases that interfere with acne counts * active liver disease * screening elevations in liver function tests * positive serology for hepatitis b or c * use of theophylline, warfarin, or propranolol within 7 days of study * use of singulair or accolate within 14 days of study * female patients who are pregnant or nursing

Keywords: leukotrienes inflammation
lams choledochoduodenostomies: with or without coaxial plastic stent

Conditions: Biliary Obstruction; Pancreatic Cancer; Biliary Tract Neoplasms

Summary: the aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (lams) with and without a coaxial double-pigtail plastic stent (dps) in eus-guided choledochoduodenostomies (cds) for the management of biliary obstruction.

the introduction of specific biliary lumen-apposing metal stents (lams) represented a great technical improvement in eus-guided transmural biliary drainage (bd) of distal malignant biliary obstruction data is still limited, but recent studies and reviews have been reported with acceptable technical and clinical success. however, some concerns exist regarding its safety, as secondary adverse events there are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (dps) within the lumen-apposing metal stents (lams) in the eus-guided choledochoduodenostomy (cds). our hypothesis is that adding a coaxial plastic stent may offer benefits in terms of safety in cds.

Eligibility criteria:
inclusion criteria: * distal biliary strictures, * a prior failed attempt at biliary drainage * informed consent provided by the patient. patient exclusion criteria were as follows: * younger than age 18 years, * coagulopathy (international normalized ratio \>1.5, marked thrombocytopenia with a platelet count \<50,000/ml, or patient on anticoagulation therapy), * critical illness.

Keywords: choledochoduodenostomy; therapeutic endoscopy lumen apposing metal stent biliary drainage
influence of intraoperative blood salvage and autotransfusion on tumor recurrence after deceased donor liver transplantation

Conditions: Liver Transplant; Complications

Summary: the practice of intraoperative blood salvage and autotransfusion (ibsa) during deceased donor liver transplantation (ddlt) for hepatocellular carcinoma (hcc) can potentially reduce the need for allogeneic blood transfusion. however, implementing ibsa remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. hence, a nationwide multi-center study was conducted to investigate further the association between ibsa and post-transplant hcc recurrence, including a stratified subgroup analysis.


Eligibility criteria:
inclusion criteria: * adult-to-adult deceased donor liver transplantation for hepatocellular carcinoma exclusion criteria: * patients under 18 years of age * presence of extrahepatic metastasis * combined kidney transplantation * reduced-size or split liver transplantation * re-transplantation
myocardial infarction prediction

Conditions: Myocardial Infarction; Artificial Neural Network

Summary: prediction of mi in patients with chest pain and nondiagnostic ecg was done in 2 weeks

myocardial infarction remains one the leading causes of mortality and morbidity and involves a high cost of care. early prediction can be helpful in preventing the development of myocardial infarction with appropriate diagnosis and treatment. artificial neural networks have opened new horizons in learning about the natural history of diseases and predicting cardiac disease. methods: a total of 935 cardiac patients with chest pain and nondiagnostic electrocardiogram (ecg) were enrolled and followed for 2 weeks in two groups based on the appearance of myocardial infarction. two types of data were used for all patients: nominal (clinical data) and quantitative (ecg findings). two different artificial neural networks - radial basis function (rbf) and multi-layer perceptron (mlp) - were used.

Eligibility criteria:
inclusion criteria: * patient with chest pain refered to er with nondiagnostic ecg exclusion criteria: * 1) absence of a history of myocardial infarction * 2) absence of bundle branch block, wolf-parkinson-white abnormality, ventricular hypertrophy or previous ecg signs of myocardial infarction, * 3) absence of a history of percutaneous coronary surgery or coronary artery bypass grafting, * 4) absence of ecg abnormalities attributable to drugs such as digoxin or tricyclic antidepressants.

Keywords: myocardial infarction artificial neural networks electrocardiography
"evaluation of clinical and radiographic results of pseudarthrosis of clavicle treated with plaque and screws"

Conditions: Pseudoarthrosis of the Clavicle

Summary: this is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle

the aim of our study is to collect clinical and radiographic data from patients operated for pseudoarthrosis of the clavicle from 2007 to 2017 at the rizzoli orthopedic institute, in order to evaluate the clinical and radiographic results of the treatment. this is an interventional study and patients will be contacted by telephone to verify their willingness to perform a visit (including a bilateral radiographic) at the rizzoli orthopedic institute

Eligibility criteria:
inclusion criteria: 1. 18-65 years of pseudarthrosis intervention 2. males and females 3. patients treated for pseudoarthrosis of the clavicle between 2007 and 2017 at the rizzoli orthopedic institute exclusion criteria: 1. floating shoulder 2. subjects who present contraindications to radiographic examination at the time of telephone contact

Keywords: pseudoarthrosis clavicle
the effects of methotrexate therapy on st segment elevation myocardial infarctions (tethys trial)

Conditions: Myocardial Infarction

Summary: experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce the inflammatory profile in acute ischemic disease and reduce the area of ischemia. methotrexate is a drug that has shown promise in ischemic disease in animal studies.

atherosclerosis and ischemic disease have clear association with inflammation. there is an anti-inflammatory action of methotrexate by increasing adenosine. experimental studies demonstrate reduction of infarct induced in animals treated with methotrexate. we expect a reduction in the area under the curve of creatine kinase (ck), creatine kinase mb fraction (ck-mb) and troponin i high sensitive, decreased levels of b-type natriuretic peptide (bnp) and improvement in left ventricular ejection fraction.

Eligibility criteria:
inclusion criteria: * age over 18 years; * chest pain suggestive of acute myocardial infarction initiated within 12 hours; * electrocardiogram with st-segment elevation greater than or equal to 0.2 mv in at least 2 contiguous leads; * choice of primary angioplasty exclusion criteria: * prior acute myocardial infarction; * prior heart failure; * angioplasty in the last 3 months; * cardiac arrest or cardiogenic shock; * history of renal insufficiency (serum creatinine greater than 2.0 mg/dl); * history of alcohol abuse (consumption equal to or greater than 20 drinks per week); * illicit drug use; * evidence of rheumatoid arthritis; * neoplasia; * infectious diseases; * prior anemia (hematocrit below 30%); * use of anti-inflammatory hormonal or non-hormonal last week; * xanthines excessive consumption (more than two and a half cups of coffee or two and a half mate gourds); * pregnancy; * disagreement with the term of consent;

Keywords: myocardial ischemia myocardial infarction methotrexate inflammation anti-inflammatory agents inflammation mediators
a study to investigate the safety, toleration and pharmacokinetics of single oral doses of pf-03864086 in healthy male subjects

Conditions: Pain

Summary: the purpose of this study is to determine the safety and tolerability of pf-03864086 in healthy male human volunteers. determine the pharmacokinetics (calculations of the rate of elimination of pf-03864086 from the body once the compound is ingested).


Eligibility criteria:
inclusion criteria: * healthy male volunteers * no drug history * no other medication for 28 pre-dose exclusion criteria: * age below 21 years * age above 55 years

Keywords: phase 1, human study, healthy volunteers
a study of rituximab (mabthera) subcutaneous (sc) versus rituximab (mabthera) intravenous in participannts with follicular non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab sc versus rituximab iv in participants with previously untreated follicular non-hodgkin's lymphoma. participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as iv infusion or 1400 milligrams (mg) rituximab sc. in addition, participants will receive standard chemotherapy. participants who achieved a complete or partial response (pr) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. maintenance treatment cycles will be repeated every 8 weeks. this is a two-stage study. stage 1 was designed to confirm the chosen rituximab sc dose resulting in comparable rituximab serum ctrough levels compared with rituximab iv, when given as part of induction treatment every 3 weeks. enrollment for stage 2 started after the rituximab sc dose was established in stage 1. stage 2 aimed to further investigate the efficacy and safety of rituximab sc compared with rituximab iv. the anticipated time on study treatment is 96 weeks.


Eligibility criteria:
inclusion criteria: * cluster of differentiation 20 (cd20)-positive, follicular non-hodgkin's lymphoma grade 1, 2, 3a. a tumor biopsy must have been performed within 6 months before study entry with material available for central review * no prior treatment * eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: * grade 3b follicular lymphoma * transformation to high-grade lymphoma secondary to follicular lymphoma * types of non-hodgkin's lymphoma other than follicular lymphoma * presence or history of central nervous system (cns) disease * corticoid therapy during the last 4 weeks, except prednisone treatment less than (\<) 20 milligrams per day (mg per day) * known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with iv antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication
fluoride availability in saliva after use of sodium fluoride or monofluorophosphate toothpastes

Conditions: Dental Caries

Summary: considering the widespread use of sodium fluoride (naf) and monofluorophosphate (mfp) based toothpastes, the present study aim to evaluate f availability in saliva after use of the top-selling brazilian toothpastes. in a blind, crossover clinical trial study, volunteers will brush their teeth with one of the following toothpastes: 1) non-fluoride toothpaste (negative control group); 2) naf/silica based toothpaste 3)mfp/calcium carbonate based toothpaste. after brushing, a rinse with purified water will be performed. unstimulated saliva will be collected before and up to 60 min after brushing. ionic fluoride and total soluble fluoride (corresponding to the sum of fluoride as ion and as mfp) will be determined after acid treatment of salivary samples to hydrolyze mfp. fluoride will be determined using an ion selective electrode.


Eligibility criteria:
inclusion criteria: * good general health * good oral health * normal salivary flow rate exclusion criteria: * use of systemic drugs that reduce salivary flow rate

Keywords: toothpastes saliva dental caries fluoride
empagliflozin as adjunctive to insulin therapy over 52 weeks in patients with type 1 diabetes mellitus (ease-2)

Conditions: Diabetes Mellitus, Type 1

Summary: comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii). randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.


Eligibility criteria:
inclusion criteria: * male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (t1dm) for at least 1 year at the time of visit 1 * fasting c-peptide value of \< 0.7 ng/ml (0.23 nmol/l) at visit 2 measured by the central laboratory * use of, and be willing, based on the investigator's judgement, to continue throughout the duration of the trial, either: * multiple daily injections (mdi) of insulin consisting of at least one basal insulin injection and at least three daily bolus injections or * continuous subcutaneous insulin infusion (csii) of any insulin type, with at least 5 months experience of using csii prior to visit 1 * hba1c \>/= 7.5% and \</= 10.0% at visit 5 measured by the central laboratory * age \>/= 18 years at visit 1 additional inclusion criteria may apply exclusion criteria: * history of type 2 diabetes mellitus (t2dm), maturity onset diabetes of the young (mody), pancreatic surgery or chronic pancreatitis * pancreas, pancreatic islet cells or renal transplant recipient * t1dm treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, glucagon-like-peptide 1 (glp-1) analogues, sodium-glucose co-transporter (sglt-2) inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to visit 1 * occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to visit 1 and until randomisation * occurence of diabetic ketoacidosis (dka) within 3 months prior to visit 1 and until randomisation additional exclusion criteria may apply
french cohort evaluating the effectiveness of atrioventricular synchrony by the micra av

Conditions: Atrioventricular Synchrony by the Micra AV

Summary: transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous pacemakers. the absence of atrial pacing has restricted their uses mainly for cases of paroxysmal atrioventricular block (avb) or avb with atrial fibrillation. the micra av contains an embedded accelerometer that senses the atrial contraction waveform, allowing the ventricle to be paced once the atrial contraction is complete. this atrioventricular synchronization is intended to extend the use of the device to cases of permanent complete avb with normal sinus function. two randomized clinicals trials have been proven it's efficacy. however, with av-cesar cohort, we aim to evaluate the real word effectiveness of micra av, in the first 1000 patients implanted by the device in france.


Eligibility criteria:
inclusion criteria: * all patients who underwent micra av implantation exclusion criteria: * refusal of consent

Keywords: pacemaker syndrome dual chamber pacemaker upgrade quality of life sf36 questionnaire effectiveness complications